Service d'orthopédie, CHU Lille, Hôpital Salengro, place de Verdun, 59000 Lille, France; Université de Lille, 59000 Lille, France; University of Lille, CHU of Lille, ULR2694-METRICS: évaluation des technologies de santé et des pratiques médicales, 59000 Lille, France; Department of biostatistics, CHU Lille, 59000 Lille, France.
Service d'orthopédie, CHU Lille, Hôpital Salengro, place de Verdun, 59000 Lille, France; Université de Lille, 59000 Lille, France.
Orthop Traumatol Surg Res. 2021 May;107(3):102830. doi: 10.1016/j.otsr.2021.102830. Epub 2021 Jan 29.
The impact of surgery on the patient is classically assessed on pre- and post-treatment scores. However, it is increasingly recommended to rank these results according to the minimal clinically important difference (MCID), using either the data distribution method or the anchor method, latter consisting in an extra question specifically targeting the patient's improvement. MCIDs vary between populations and, to the best of our knowledge; there have been no investigations in France regarding this in the context of total hip replacement (THR). Therefore, we conducted a prospective study in a population with THR to determine: 1) whether MCID scores in France were comparable to those reported in the data from the international literature; 2) whether a general item taken from a different score could serve as an anchor; and 3) whether an item from the actual questionnaire itself could serve as an anchor.
When pre- and post-treatment scores are available, an item from the questionnaire itself can serve as an anchor for MCID.
In a prospective observational study, 123 primary THR patients (69 male, 54 female), out of 150 initially included, completed the 5 domains of the HOOS hip disability and osteoarthritis outcome score and the Oxford-12 questionnaire, preoperatively and at 6-12 months. The MCID was calculated via the distribution-based and the anchor-based methods. Two Oxford items (questions 1 and 2) and 2 HOOS items (questions S1 and Q4) were used as anchors, as well as a supplementary question on improvement and the Forgotten Joint Score (FJS).
At a mean 10.12±1.2 months' follow-up [range, 6.5-11.9 months], the Oxford-12 score increased from 19±8 [3-35] to 40±10 [8-48] (p<0.001), all HOOS components demonstrated improvement, and the FJS at the final follow-up was 71±29 [0-100]. The general items (Oxford question 1 and HOOS question Q4) were more discriminating than the joint-specific items (Oxford question 2 and HOOS question S1). Based on results from the 3 anchors (improvement rated 1 to 5, Oxford question 1 and HOOS question Q4), 3 to 5 patients showed deterioration, 5 to 6 were unchanged, 30 to 40 were slightly improved, and 73 to 80 were improved by THR. The mean MCID on both distribution and anchor methods was 9 [5.5-12] for Oxford-12, 20 [12-27] for HOOS symptoms, 26 [10-36] for HOOS pain, 22 [11.5-28] for HOOS function, 26 [13-34] for HOOS sport and 22 [14-28] for HOOS quality of life.
The MCID for the Oxford-12 and HOOS scores in a French population was comparable to data from the past literature. Using a score item as an anchor to define improvement is possible, but only if a general item is used.
IV; prospective study without control group.
NCT04057651.
手术对患者的影响通常通过治疗前后的评分来评估。然而，越来越多的人建议根据最小临床重要差异（MCID）对这些结果进行排名，可使用数据分布法或锚定法，后者由一个专门针对患者改善情况的附加问题组成。MCID 在不同人群中有所差异；据我们所知，在法国，还没有关于全髋关节置换术（THR）方面的研究。因此，我们进行了一项前瞻性研究，对 THR 患者进行了调查，以确定：1）法国的 MCID 评分是否与国际文献中的数据报告相似；2）不同评分中的一般项目是否可以作为锚定；3）实际问卷中的项目是否可以作为锚定。
当有治疗前后的评分时，问卷本身的项目可以作为 MCID 的锚定。
在一项前瞻性观察性研究中，123 名初次接受 THR 的原发性髋关节疾病患者（69 名男性，54 名女性）完成了髋关节骨关节炎结果评分 HOOS 问卷的 5 个领域和牛津 12 项问卷，分别在术前和术后 6-12 个月进行。通过基于分布和基于锚定的方法计算 MCID。使用了两个牛津问题（问题 1 和 2）和两个 HOOS 问题（问题 S1 和 Q4）作为锚定，以及一个关于改善情况的附加问题和遗忘关节评分（FJS）。
在平均 10.12±1.2 个月的随访期[范围，6.5-11.9 个月]中，牛津 12 项评分从 19±8[3-35]增加到 40±10[8-48]（p<0.001），所有 HOOS 成分均有改善，最后一次随访时的 FJS 为 71±29[0-100]。一般项目（牛津问题 1 和 HOOS 问题 Q4）比关节特异性项目（牛津问题 2 和 HOOS 问题 S1）更具区分度。基于 3 个锚定（1-5 分评定改善、牛津问题 1 和 HOOS 问题 Q4）的结果，3-5 例患者出现恶化，5-6 例无变化，30-40 例轻微改善，73-80 例接受 THR 后有改善。在分布和锚定方法中，牛津 12 项的 MCID 平均值为 9[5.5-12]，HOOS 症状为 20[12-27]，HOOS 疼痛为 26[10-36]，HOOS 功能为 22[11.5-28]，HOOS 运动为 26[13-34]，HOOS 生活质量为 22[14-28]。
法国人群的牛津 12 项和 HOOS 评分的 MCID 与过去文献中的数据相似。使用评分项目作为锚定来定义改善是可行的，但只能使用一般项目。
IV；无对照的前瞻性研究。
NCT04057651。
